Coronavirus COVID-19 Vaccines

William M. Detmer, MD, supported by the Unbound Medicine Team

Updated: November 30, 2020

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COVID-19 Vaccines in Phase 3 Trials

  • Multiple vaccines are under development. Eleven are under investigation in Phase 3 trials (Table 1 below), 48 are in clinical trials (Table 2), and 151 in preclinical evaluation.[1]
  • For overview of trial design, see Clinical Trial Phases and Definitions
  • Among those with the greatest potential for speed are DNA- and RNA-based platforms, followed by those for developing recombinant-subunit vaccines.
  • RNA and DNA vaccines can be made quickly because they require no culture or fermentation, instead using synthetic processes.
Table 1. COVID-19 Candidate Vaccines in Phase 3 Trials

Developer

#

Phase 1*

Phase II

Phase III

Warp SpeedBioNTech/ Pfizer
BNT162

2

NCT04368728
Results in NEJM[2]

NCT04537949
Results in Nature[3]

NCT04537949
Positive final results.[4],[5]

Warp SpeedModerna/ NIAID
mRNA-1273

2

NCT04283461
Results in NEJM[6],[7]

NCT04405076

NCT04470427

Positive final results.[8],[9]

Warp SpeedUniversity of Oxford/ AstraZeneca
AZD1222

2

NCT04324606
Results in Lancet[10]

NCT04516746
Positive interim results.[11]

Sinovac
CoronaVac

2

NCT04383574
NCT04352608
Results in Science[12]

NCT04456595

Wuhan Institute of Biological Products/ Sinopharm
Inactivated virus

2

ChiCTR-2000031809
Results in JAMA[13]

ChiCTR-2000034780

Beijing Institute of Biological Products/ Sinopharm
BBIBP-CorV

2

ChiCTR-2000032459
Results in Lancet Infect Dis[14]

ChiCTR-2000034780

Bharat Biotech
BBV152

2

CTRI/2020/07/026300

CTRI-2020/11/028976

CanSino Biological Inc/ Beijing Institute of Biotechnology
Ad5-nCoV

1

NCT04313127
Results in Lancet[15]

NCT04341389
Results in Lancet[16]

NCT04526990; NCT04540419

Gamaleya Research Institute
Gam-COVID-Vac

2

NCT04437875;
Results in Lancet[17]

NCT04587219

NCT04530396

Warp SpeedJanssen Pharmaceutical Companies
Ad26.COV2.S

2

NCT04436276

NCT04505722

Warp SpeedNovavax
NVX-CoV2373

2

NCT04368988
Results in NEJM[18]

2020-004123-16

# Number of vaccine doses required

*Trials spanning Phase 1 and 2 represent Phase 1/2 trials.

LNP = lipid nanoparticle; RBD = receptor-binding domain; mRNA = messenger RNA; VLP = virus-like particles

Warp SpeedRecipient of U.S. Operation Warp Speed Funding

Recent News

RECENT UPDATES

  • Moderna mRNA-1273 vaccine
    • Phase 3 trial final results reported in a company press release showed vaccine efficacy of 94.1% against infection and 100% against severe COVID-19.[9] Results have not yet been published in a peer-reviewed journal. Final analysis performed after 196 COVID-19 were confirmed. Remarkably, 30 severe cases were observed — all in the placebo group and none in the vaccine group. Efficacy was consistent across age, race and ethnicity, and gender demographics. No serious side effects were observed. Company plans to submit for an Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA) today. [November 30]
    • Phase 3 study interim results reported in a company press release showed reduction of COVID-19 infection by 95% in vaccine recipients.[8] Results have not yet been published in a peer-reviewed journal. Study enrolled more than 30,000 participants to date and the first interim efficacy analysis was conducted when 95 COVID-19 cases were confirmed beginning two weeks after the second dose. Of these cases, 90 cases of COVID-19 were observed in the placebo group versus 5 in the vaccine group. Eleven severe cases were reported – all 11 cases occurred in the placebo group and none in the vaccine group. No serious side effects were reported. The trial is continuing to enroll and is expected to continue through the final analysis. [November 16]
    • Results of Phase 1 clinical trial in older adults (56+ years of age) published in the New England Journal of Medicine[7] showed a robust antibody and cellular immune response in vaccinated individuals. Mild-moderate side effects were common but self-limited. [September 29]
    • Preclinical study in non-human primates reported in New England Journal of Medicine.[19] Two injections elicited high levels of neutralizing antibody and Th1 CD4 T-cell responses in rhesus macaques. Two days after challenge of vaccinated animals with intranasal and intratracheal virus, viral replication was undetectable in bronchoalveolar-lavage fluid and nasal secretions. [July 28]
    • Phase 1 study published in NEJM.[6] Forty-five adults age 18–55 were tested with one of three dose levels given as 2 vaccinations 28 days apart. All subjects produced antibodies and neutralizing activity on par with natural infection. Mild-moderate side effects were common. [July 14]
  • University of Oxford / AstraZeneca AZD1222 vaccine
    • Phase 3 trial interim results reported in a company press release showed reduction of COVID-19 infection by 70% in vaccine recipients.[8][11] Results have not yet been published in a peer-reviewed journal. Study enrolled more than 23,000 participants to date in the UK and Brazil and the first interim efficacy analysis was conducted when 131 COVID-19 cases were confirmed beginning two weeks after the second dose. One dosing regimen showed vaccine efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose at least one month apart, and another dosing regimen showed 62% efficacy when given as two full doses at least one month apart (for a combined average efficacy of 70%). No hospitalizations for severe COVID-19 cases were reported in the group receiving a vaccine. Based on these results, the company intends to submit for an Emergency Use Authorization (EUA) with the World Health Organization in coming weeks. [November 23]
    • Phase 3 trial resumed in the US after safety review by the FDA.[20] [October 23]
    • Phase 3 trial resumed in the UK[21] (where the case of transverse myelitis occurred) but not yet in the United States, due to safety concerns at the NIH and FDA. [September 12]
    • Phase 3 trial paused[22] due to a trial participant developing a serious neurological event, thought to be transverse myelitis[23]. Transverse myelitis is a rare disorder of the spinal cord that, like Guillain-Barré syndrome, can be triggered by certain viral infections, including SARS-CoV-2 itself. Investigators and the U.S. National Institutes of Health have pledged to fully investigate whether this case could be associated with the vaccine. [September 9]
    • Preclinical study in rhesus macaques reported in Nature[24] showed that a single vaccination with ChAdOx1 nCoV-19 is effective in preventing damage to the lungs upon high dose challenge to both upper and lower respiratory tract with SARS-CoV-2; there was also no evidence of immune-enhanced disease in vaccinated animals. However, in regard to possible infectivity, nasal shedding of the virus was not significantly different between vaccinated and control animals. [July 30]
    • Phase 1/2 trial published in Lancet[25] showed that in adults age 18–55 a single dose elicited both humoral and cellular responses against SARS-CoV-2, with a booster immunization augmenting neutralizing antibody titres. No serious adverse effect were reported; mild-moderate side effects were common. [July 20]
    • Phase 3 trials that are underway in Brazil, South Africa, and the UK.
  • BioNTech/Pfizer BNT162 vaccine
    • Phase 3 trial concluded showing reduction of COVID-19 infection by 95% in vaccine recipients.[5] In 43,661 participants, 170 confirmed cases of COVID-19 were evaluated, with 162 observed in the placebo group versus 8 in the vaccine group. Companies plan to submit and Emergency Use Authorization (EUA) within days to the FDA. [November 18]
    • Phase 3 study interim results reported in a company press release showed reduction of COVID-19 infection by 90% in vaccine recipients.[4] Results have not yet been published in a peer-reviewed journal. Study enrolled 43,538 participants to date and the first interim efficacy analysis was conducted when 94 COVID-19 cases were confirmed. The case split between vaccinated individuals and those who received the placebo indicated a vaccine efficacy rate above 90%, at 7 days after the second dose (given at day 28). No serious side effects were reported. The trial is continuing to enroll and is expected to continue through the final analysis when a total of 164 confirmed COVID-19 cases have accrued. [November 9]
    • Phase 1/2 trial published in Nature[26] showed that 60-person subset in immunized individuals generate a robust SARS-CoV-2-sepcific antibody and cellular mediated immune response which suggests multiple mechanisms with potential to protect against COVID-19. [September 30]
    • Phase 1/2 trial results published in Nature[3] showing that in 36 healthy adults 18–55 who received 2 doses of vaccine separated by 21 days developed RBD-binding and neutralizing antibodies higher than with natural infection. Mild to moderate side effects were common. [August 12; preprint published July 1]
    • U.S. government ordered 100 million doses of BNT162 for $1.95 billion as part of the U.S. Warp Speed program. A Phase 2b/3 safety and efficacy trial for the vaccine begins in late July 2020.[27][July 22]
  • Johnson & Johnson/Janssen Ad26.COV2-S vaccine
    • Trials resumed in the US after safety review by the company and an independent Data Safety Monitoring Board (DSMB) found no evidence that the vaccine candidate caused the medical event experienced by one study partipant.[28] [October 23]
    • All trials of this vaccine paused (including Phase 3 trial)[29] due to an unexplained illness in a study participant. The company and a DSMB are investigating. [October 12]
    • Phase 3 trial (ENSEMBLE) begun with 60,000 partipants from mulitple country.[30] [September 23]
    • Preclinical study in rhesus macaques reported in Nature[31] showed a single dose of the adenovirus serotype 26 (Ad26) vector-based vaccine induced robust neutralizing antibody responses and provided complete or near-complete protection in bronchoalveolar lavage and nasal swabs following SARS-CoV-2 challenge. [July 30]
    • Phase 1/2 trial began in late July.
    • The company received Warp Speed funding of $456 million for pre-clinical and Phase 1 clinical trials. [March 30]
  • INOVIO INO-4800 vaccine
    • Phase 2/3 has been put on partial clinical hold until questions posed by the U.S. FDA about the candidate and the delivery device (CELLECTRA® 2000) have been satisfactorily addressed. This hold is not due to the occurrence of any adverse events. [September 28]
    • Reports in a press release success of DNA-based vaccine INO-4800 in Phase 1 trial.[32][June 30]
  • Novavax NVX-CoV2373 vaccine
    • Phase 3 trial begins with 10k participants in the UK.[33] A similar trial is expected to start in the U.S in October. [September 24]
    • Phase 1/2 trial published in New England Journal of Medicine[18] showed that in 106 healthy adults age 18–59 who received two doses spaced 21 days apart had robust immune responses with both IgG and neutralization antibodies 4-fold higher than seen in natural infection. Mild-moderate side effects were common and greater local and systemic reactogenicity occurred with the second dose. [September 2]
    • Received U.S. Warp Speed funding for protein-based vaccine development and clinical trials.[34][July 7]
  • Gamaleya Research Institute Gam-COVID-Vac vaccine
    • Phase 1/2 trial results published in Lancet[17] showed 76 adults receiving one of two vaccine types (rAd26-S or rAd5-S) either alone or with a booster at 21 days generated both neutralizing and specific IgG antibodies. Mild-moderate side effects (pain at injection site, fever, headache, myalgia) were common, but no major side effects were reported. [September 4]
    • Phase 1 trials of this vaccine were registered in June 2020 but no results have have been published in the scientific literature. Despite this, Russian President Vladimir Putin announced regulatory approval of the vaccine (to be called "Sputnik V" in foreign markets). Mass vaccination in Russia is expected to start in October 2020.[35][August 11]
  • Sanofi/GSK protein subunit vaccine
    • Phase 1/2 trial initiated with 400+ participants. [September 3]
    • Sanofi reported it had secured an agreement with the U.S. government to provide 100 million doses of its experimental vaccine for up to $2.1 billion as part of Operation Warp Speed. [July 31]
  • Wuhan Institute of Biological Products / Sinopharm β-propiolactone-inactivated-whole-virus vaccine
    • Interim analysis of a Phase 1/2 trial reported in JAMA[13] showed that in 225 healthy adults aged 18–59 two injections of a medium dose spaced 21 days apart generated the most neutralizing and specific IgG antibodies and those levels were reported to be comparable to other vaccine candidates (but no direct comparisons was made to those vaccines or to convalescent plasma). Side effects were mild, self-limited and lower in frequency than what has been reported for other vaccine types. [August 13]
  • BioNTech/Pfizer BNT162 vaccine
    • Phase 1/2 trial results published in Nature[3] showing that in 36 healthy adults 18–55 who received 2 doses of vaccine separated by 21 days developed RBD-binding and neutralizing antibodies higher than with natural infection. Mild to moderate side effects were common. [August 12; preprint published July 1]
    • U.S. government ordered 100 million doses of BNT162 for $1.95 billion as part of the U.S. Warp Speed program. A Phase 2b/3 safety and efficacy trial for the vaccine begins in late July 2020.[27][July 22]
  • CanSino Biologics Adenovirus Type 5 vectored vaccine
    • Phase 2 trial published in Lancet[16] showed that in 382 adults age ≥ 18 a single dose induced cellular or humoral immune responses at day 28 post vaccination in 91–95% of recipients depending on the dose. Mild-moderate side effects were common; Grade 3 adverse effects were seen in 9%. [July 20]
    • Received Military Specially-needed Drug Approval (軍隊特需藥品批件) for non-replicating adenovirus vaccine Ad5-nCoV for use in the Chinese military.[36][June 25]
  • INOVIO reports in a press release success of DNA-based vaccine INO-4800 in Phase 1 trial.[32][June 30]

COVID-19 Vaccines in Clinical Trials

Table 2. COVID-19 Candidate Vaccines Undergoing Clinical Evaluation

Developer

Platform

Type

Current stage

Warp SpeedModerna/ NIAID

RNA

LNP-encapsulated mRNA (mRNA-1273)

Phase 3 NCT04470427; Positive final results.[8],[9]

Phase 2 NCT04405076

Phase 1 NCT04283461; Results in NEJM[6],[7]

Warp SpeedBioNTech/ Fosun Pharma/ Pfizer

RNA

3 LNP-mRNAs (BNT162)

Phase 3 NCT04368728; Positive final results.[4],[5]

Phase 1/2 NCT04537949; Results in Nature[3]

Warp SpeedUniversity of Oxford/ AstraZeneca

Non-Replicating Viral Vector

Weakened adenovirus (ChAdOx1-S; AZD1222)

Phase 3 NCT04516746; Positive interim results.[11]

Phase2b/3 NCT04400838

Phase 1/2 PACTR202006922165132; 2020-001072-15; Results in Lancet[15]

Sinovac

Inactivated

Inactivated + alum (CoronaVac; formerly PiCoVacc)

Phase 3 NCT04456595

Phase 1/2 NCT04383574 ; NCT04352608; Results in Science[12]

Wuhan Institute of Biological Products/ Sinopharm

Inactivated

Inactivated

Phase 3 ChiCTR2000034780

Phase 1/2 ChiCTR2000031809; Results in JAMA[13]

Beijing Institute of Biological Products/ Sinopharm

Inactivated

Inactivated (BBIBP-CorV)

Phase 3 ChiCTR2000034780

Phase 1/2 ChiCTR2000032459

CanSino Biological Inc./ Beijing Institute of Biotechnology

Non-Replicating Viral Vector

Adenovirus Type 5 Vector (Ad5-nCoV)

Phase 3 NCT04526990; NCT04540419

Phase 2 NCT04341389; Results in Lancet[16]

Phase 1 NCT04313127; Results in Lancet[15]

Gamaleya Research Institute

Non-Replicating Viral Vector

Adenovirus-based (Gam-COVID-Vac; Гам-КОВИД-Вак)

Phase 3 NCT04530396

Phase 1 NCT04436471; NCT04437875; Results in Lancet[17]

Anhui Zhifei Longcom Biopharmaceutical/ Institute of Microbiology, Chinese Academy of Sciences

Protein Subunit

Adjuvanted recombinant protein (RBD-Dimer)

Phase 2 NCT04466085

Phase 1 NCT04445194

Inovio Pharmaceuticals / International Vaccine Institute

DNA

DNA plasmid vaccine with electroporation (INO-4800)

Phase 1/2 NCT04336410; NCT04447781

Warp SpeedNovavax

Protein Subunit

Recombinant SARS CoV-2 glycoprotein nanoparticle vaccine adjuvanted with Matrix M (NVX-CoV2373)

Phase 3 2020-004123-16

Phase 2b NCT04533399

Phase 1/2 NCT04368988; Results in NEJM[18]

Warp SpeedJanssen Pharmaceutical Companies

Non-Replicating Viral Vector

Ad26.COV2.S

Phase 3 NCT04505722

Phase 1/2 NCT04436276

Bharat Biotech

Inactivated

Whole-Virion Inactivated

Phase 1/2 CTRI/2020/07/026300

Kentucky Bioprocessing, Inc

Protein Subunit

RBD-based

Phase 1/2 NCT04473690

Institute of Medical Biology, Chinese Academy of Medical Sciences

Inactivated

Inactivated

Phase 1/2 NCT04470609

Phase 1 NCT04412538

Warp SpeedSanofi Pasteur/GSK

Protein Subunit

S protein (baculovirus production

Phase 1/2 NCT04537208

Research Institute for Biological Safety Problems, Rep of Kazakhstan

Inactivated

Inactivated

Phase 1/2 NCT04530357

SpyBiotech/Serum Institute of India

VLP

RBD-HBsAg VLPs

Phase 1/2 ACTRN12620000817943

Genexine Consortium

DNA

DNA Vaccine (GX-19)

Phase 1 NCT04445389

Cadila Healthcare Limited

DNA

DNA plasmid vaccine

Phase 1/2 CTRI/2020/07/026352

Osaka University/ AnGes/ Takara Bio

DNA

DNA plasmid vaccine + Adjuvant

Phase 1 JapicCTI-205328

Gamaleya Research Institute

Non-Replicating Viral Vector

Adenovirus-based (Gam-COVID-Vac; Гам-КОВИД-Вак)

Phase 1 NCT04436471; NCT04437875

Clover Biopharmaceuticals Inc./ GSK/ Dynavax

Protein Subunit

Native like Trimeric subunit Spike Protein vaccine (SCB-2019)

Phase 1 NCT04437875

Arcturus/Duke-NUS

RNA

mRNA

Phase 1/2 NCT04480957

Vaxine Pty Ltd/ Medytox

Protein Subunit

Recombinant spike protein with Advax™ adjuvant

Phase 1 NCT04453852

University of Queensland/ CSL/ Seqirus

Protein Subunit

Molecular clamp stabilized Spike protein with MF59 adjuvant

Phase 1 ACTRN12620000674932p

Imperial College London

RNA

LNP-nCoVsaRNA

Phase 1 ISRCTN17072692

Curevac

RNA

mRNA

Phase 1 NCT04449276

Medigen Vaccine Biologics Corporation/ NIAID/ Dynavax

Protein Subunit

S-2P protein + CpG 1018

Phase 1 NCT04487210

People’s Liberation Army (PLA) Academy of Military Sciences/Walvax Biotech

RNA

mRNA

Phase 1 ChiCTR2000034112

Medicago Inc./ Université Laval

VLP

Plant-derived VLP

Phase 1 NCT04450004

Institute Pasteur/ Themis/ Univ. of Pittsburg CVR/ Merck Sharp & Dohme

Replicating Viral Vector

Measles-vector based

Phase 1 NCT04497298

ReiThera/ LEUKOCARE/ Univercells

Non-Replicating Viral Vector

Replication defective Simian Adenovirus (GRAd) encoding S

Phase 1 NCT04528641

Instituto Finlay de Vacunas, Cuba

Protein Subunit

RBD + Adjuvant

Phase 1 IFV/COR/04

FBRI SRC VB VECTOR, Rospotrebnadzor, Koltsovo

Protein Subunit

Peptide

Phase 1 NCT04527575

West China Hospital, Sichuan University

Protein Subunit

RBD (baculovirus production expressed in Sf9 cells)

Phase 1 ChiCTR2000037518

University Hospital Tuebingen

Protein Subunit

SARS-CoV-2 HLA-DR peptides

Phase 1 NCT04546841

COVAXX

Protein Subunit

S1-RBD-protein

Phase 1 NCT04497298

Beijing Wantai Biological Pharmacy/ Xiamen University

Replicating Viral Vector

Intranasal flu-based-RBD

Phase 1 ChiCTR2000037782

Vaxart

Non-Replicating Viral Vector

Ad5 adjuvanted Oral Vaccine platform

Phase 1 NCT04563702

Ludwig-Maximilians - University of Munich

Non-Replicating Viral Vector

MVA-SARS-2-S

Phase 1 NCT04569383

Adapted from Draft landscape of COVID-19 candidate vaccines. WHO. 12 November 2020.[1]

LNP = lipid nanoparticle; RBD = receptor-binding domain; mRNA = messenger RNA; VLP = virus-like particles

Warp SpeedRecipient of U.S. Operation Warp Speed Funding[37],[38]

COVID-19 Vaccine Trial Phases and Definitions

Preclinical Testing

In a Preclinical trial, the vaccine is given to animals such as mice or monkeys, typically rhesus macaques (Macaca mulatta), to see if it produces an immune response.

Phase 1

In a Phase I trial, the vaccine candidate is given to a small number of people to test safety and dosage as well as to confirm that it stimulates the immune system.

Phase 2

In a Phase II trial, the vaccine candidate is given to hundreds of people split into different age or risk groups groups to see if the vaccine acts differently in different populations. These trials further test the vaccine’s safety and ability to stimulate the immune system.

Phase 3

In a Phase III trial, the vaccine candidate is given to thousands of people and wait to see how many become infected, compared with those who received a placebo. These trials can determine if the vaccine protects against the coronavirus.

Approval

Regulators in each country review the trial results and decide whether to approve the vaccine or not. During a public health emergency, a vaccine may receive Emergency Use Authorization (EUA) before getting formal approval.

Phase 4

In a Phase IV trial – also known as a postmarketing surveillance trial or a confirmatory trial – the vaccine is monitored for safety, side effects and efficacy after it has been approved and made available to the public.

Warp Speed

The U.S. government’s Operation Warp Speed program is expected to name five or more vaccine projects to receive billions of dollars in federal funding before there’s proof that the vaccines work.

Combined Phases

Some coronavirus vaccines are now in combined phase trials to speed evalutation. For instance, many Phase 1/2 trials are underway to test a vaccine for the first time on hundreds of people.

COVID-19 ClinicalTrials.gov Trials

Feedback

We’d appreciate your feedback!

References

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Last updated: December 1, 2020